MAUDE Adverse Event Report: SKYTRON, LLC SKYTRON 3600B ULTRA-GLIDE; TABLE, OPERATING ROOM, AC-POWERED

Model Number 3600B

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  Injury  

Event Description

Patient was anesthetized and attached to skytron 3600b ultra-glide operating table for a robotic assisted hysterectomy.Patient was placed in a steep trendelenberg position.The levers on the underside of the table that release the individual sections of the table were depressed when they pressed against the base of the table.The table has an elevated portion which houses the machinery that operates the table.The portion of the table where the patient's upper torso, neck and head were slid off the table and fell.The staff quickly lifted the patient back up and were able to reattach the table section.An x-ray of the patient's c-spine was done and there was no apparent damage.The surgery resumed and was completed.

• Brand Name: SKYTRON 3600B ULTRA-GLIDE
• Type of Device: TABLE, OPERATING ROOM, AC-POWERED
• Manufacturer (Section D): SKYTRON, LLC; grand rapids MI 49512
• MDR Report Key: 6843363
• MDR Text Key: 84965026
• Report Number: MW5071956
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 92